BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    FLOSSAGE - ELECTRIC TOOTHFLOSSER

    FDA 510(k)
    FDA Class 1 ·Dental

    Safe'n'Sound Staked Passive Delivery System - Plajex version

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OCULIGHT GL/GLX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH INC·Product code LWS·May 22, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·June 15, 2015

    BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.

    FDA Recall
    Terminated ·Bard Brachytherapy, Inc.·Product code KXK·April 10, 2018